DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions II-V, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/01/2025.
It is acknowledged that claims 18-20 were amended to be written in a short hand version (dependent type) and utilizing the subject matter of claim 10. However, the method is still seen as restricted out as its own separate group. Further, invention II could only be elected on its own. The restriction put forth that if the invention II was elected then claim 1 would have also been considered not that invention I and invention II would be considered together. However, applicant elected invention I which only includes claims 1-9. The traversal is acknowledged. However, each group is seen as a different invention as described in the restriction. It is acknowledged however, should claim 1 be found allowable then claims 10-13 would also be seen as allowable. Claims 18-20 would require a providing the ultrasonic transducer of claim 10 limitation to deem them similar to the acknowledgement for claims 10-13. Therefore, the restriction is seen as correct and invention I will be examined.
*It is noted by the examiner that the restriction was made based on recommendations from a quality expert at the office and was overseen by said quality expert. Further, it is also noted that some of the claims may fall into product by process style claims, and it is recommended to amend to look at MPEP 2113 for how to proceed. It is also suggested that, as seen in Fig. 1 and fig. 21; the specifics of the piezoelectric device and piezoelectric nanofiber film layer are unique but not necessarily claimed in such a manner. Furthermore, the direction of the nanofibers appear to be significant as well with regards to the direction not just the alignment.
It is suggested that if applicant/applicant’s representative, would like to discuss the claimed invention/rejection below to set up a phone interview with the examiner.
Claim Objections
Claim 9 is objected to because of the following informalities: In line 4 of claim 9 its states “votage” which appears to be a misspelling. It is suggested to amend this word to be “voltage”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, 5-7 and 9 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Hosseini, “Glycine—Chitosan-Based Flexible Biodegradable Piezoelectric Pressure Sensor”, ACS Appl. Mater. Interfaces 2020, 12, 9008-9016; herein referred to as “Hosseini” provided by applicant on the IDS.
Regarding claim 1, Hosseini teaches: A composite material (Abstract) comprising: a biodegradable polymer (abstract and page 7(9014) paragraph 1: biodegradable utilizing chitosan); and a plurality of glycine crystals embedded in the biodegradable polymer (abstract and page 7(9014), paragraph 1; glycine crystals in chitosan and glycine is embedded in chitosan polymer), wherein the biodegradable polymer comprises a plurality of biodegradable fibers (page 4(9011), paragraph 1; thick fibrillar crystalline regions of glycine are observed in amorphos regions of chitosan which is seen as fibers and abstract which sets forth Glycine—Chitosane as biodegradable) substantially aligned with each other (Fig. 2c shows “substantially” aligned fibers).
Regarding claim 3, Hosseini teaches: wherein the biodegradable polymer comprises one or more of poly (L-lactic acid) (PLLA), poly(D,L-lactide-co-glycolide) (PLGA), polycaprolactone (PCL), polyglycolic acid (PGA), polyhydroxybutyrate, silk,polyvinyl alcohol, chitosan, or combinations thereof (abstract “Chitosan”).
Regarding claim 5, Hosseini teaches: wherein the plurality of glycine crystals are elongated and substantially aligned with each other (Fig. 4A-D and page 4(9011), paragraph 2; the crystals are seen as elongated and substantially aligned as they have a pattern to their formation and uniformity).
Regarding claim 6, Hosseini teaches: wherein the material comprises a weight ratio of about 0.25:1 to about 2:1 of the plurality of glycine crystals to the biodegradable polymer (page 7(9014), paragraph 1; the ratios .4:1, .8:1, 1.2:1 and 2.7:1 of glycine: chitosan which fall within the ranges).
Regarding claim 7, Hosseini teaches: wherein the material has an elastic modulus of about 10 MPa to about 2,000 MPa (Page 7 (9014); the elastic modulus of the composite film should be between 1.5 GPa and 15 GPa which overlaps the claimed range).
Regarding claim 9, this claim is seen as claiming a product by process where the product is used for determination of patentability. Therefore, if applicant thinks that the process does limit the product in a way where the process makes a “special product” as defined in the specification in some way see MPEP 2113 and respond in kind. Hosseini teaches a biodegradable glycine-chitosan material as seen in the abstract/fig. 2 and 4 and therefore teaches the product: wherein the plurality of biodegradable fibers are formed by electrospinning a mixture comprising a biodegradable polymer, a plurality of glycine crystals, and at least one solvent onto a collector drum having a speed of about 100 RPM to about 4,000 RPM at a voltage of about 10 kV to about 25 kV and at a flow rate of about 2 ml/h, at a humidity of about 30% to about 50%, or a combination thereof (Figs 2 and 4 and abstract).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Hosseini in view of Zhen, “High Efficiency Fabrication of Chitosan Composite Nanofibers with uniform Morphology via centrifugal Spinning”, Polymers (Basel), 2019 24;11(10):1550, herein referred to as “Zhen”.
Regarding claim 2, Hosseini does disclose that the chitosan fiber material does have a diameter as seen in Fig. 2c and page 6 (9013) and that it is for a nanoparticle and is thus small. Hosseini does not explicitly disclose that the diameter of said fiber is about 1-5 µm. However, Zhen does disclose that Chitosan fibers can be about 5 µm, wherein each biodegradable fiber has a diameter of about 1 µm to about 5 µm (Fig. 1; the scale is 5 µm and thus the fibers are smaller and seen as “about” 1-5 µm).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the size of the fibers used in Hosseini to better reflect the sizing as seen in Zhen. The motivation to do so would be to allow for making a nanoparticle device and make fibers that are more biocompatible as seen in Zhen, page 2.
Claim(s) 4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Hosseini.
Regarding claim 4, Hosseini discloses that the glycine crystals do have a diameter as seen in Figs. 4 and 2 where the images put the crystals within the range of nm and µm. Hosseini does not explicitly disclose the exact size of the crystalline structures of glycine. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to allow for the crystals of the biodegradable composite material of Hosseini to have each glycine crystal has a diameter of about 1 nm to about 5 µm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed material/device and a material/device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the material of Hosseini would not operate differently with the claimed diameter and since the diameter of the glycine crystals of Hosseini would have to be smaller than as the elements have low molecular weight that are used to form the overall material and the images show a nano/micro scale for the glycine—chitosan. Further, applicant places no criticality on the range claimed, indicating simply that the diameter “about” be within the claimed ranges as “about” is not given an explicit definition and the ranges only state the actual range as claimed (specification pp. [00126] and [00138]).
Regarding claim 8, Hosseini does disclose that: the material has a piezoelectric output (Fig. 6 and page 18 (9013); specifically the material can be used for pressure sensing activities utilizing a voltage of +/-40MV). However, Hosseini does not explicitly disclose that the output is of greater than 600 kPa as measured by generated acoustic pressure. However, it would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to have a greater than 600 kPa output of the material as this is a property of the material which results from the crystalline structure. Therefore, it would have been obvious to try to get the output of 600 kPa as the material would only have a specific set of outputs of pressure from the what was used to make it.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOANNE M RODDEN whose telephone number is (303)297-4276. The examiner can normally be reached Monday - Friday 9:00 AM-5:00 PM MST.
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/JOANNE M RODDEN/ Supervisory Patent Examiner, Art Unit 3794